Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT05725005
Eligibility Criteria:
Inclusion Criteria:
1. Normotensive male volunteer (PET participants).
2. Male or female volunteer of non-childbearing potential (PBMC-only participants).
3. Deemed healthy on the basis of a clinical history, physical and neurological examination, electrocardiogram (ECG), vital signs, and laboratory tests of blood and urine.
4. Agree to follow the contraception requirements of the trial.
5. Able to give fully informed written consent.
Exclusion Criteria:
1. Significant (\> 10%) recent weight change.
2. Positive tests for hepatitis B and hepatitis C, human immunodeficiency virus (HIV).
3. Severe adverse reaction to any drug.
4. Sensitivity to trial medication.
5. Drug or alcohol abuse.
6. Regular consumption of xanthine-containing products.
7. Frequent use of nicotine-containing products.
8. Severe adverse reaction to any drug.
9. Sensitivity to trial medication (all participants) or PET imaging radioligand (PET participants).
10. Use of over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) during the 7 days before the first dose of radioligand (PET participants) or trial medication (PBMC participants) (or longer if the medicine is a potential enzyme inducer), or prescribed medication during the 28 days before first dose of radioligand (PET participants) or trial medication (PBMC participants).
11. Received vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 2 weeks of screening.
12. Participation in other clinical trials of unlicensed medicines.
13. Loss of more than 400 milliliters (mL) blood, within the 3 months before the first dose of tracer (PET participants) or trial medication (PBMC participants).
14. Clinically relevant abnormal findings at the screening assessment, including ECG abnormalities (all participants) or those identified by MRI scan (PET participants only).
15. Acute or chronic illness.
16. Clinically relevant abnormal history of or concurrent medical (including neurological or psychiatric) condition.
17. Positive columbia-suicide severity rating scale (C-SSRS) result.
18. Vegan.
19. Possibility that volunteer will not cooperate.
20. Unsatisfactory venous access.
21. Objection by general practitioner (GP).
22. PET participants only: significant exposure to research related radiation (more than 10 millisievert \[mSv\]) within the previous 12 months.
23. Contraindications to arterial cannulation (e.g., allen's test indicates risk) or magnetic resonance imaging (MRI) scanning (e.g., presence of a cardiac pacemaker or other implanted electronic device or a history of claustrophobia).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
55 Years
Study:
NCT05725005
Study Brief:
Protocol Section:
NCT05725005